FDA Approves Covidien Combination Product to Treat Spasticity The U.S. Food and Drug Administration

FDA Approves Covidien Combination Product to Treat Spasticity
The U.S. Food and Drug Administration has approved Covidien plc’s Gablofen prefilled syringes. Gablofen (a brand name of baclofen) is primarily used to treat spasticity and is in the early research stages for use for the treatment of alcoholism. The prefilled syringes reportedly are designed to cut down on preparation time and make it easier for patients on intrathecal (when a drug is introduced under the arachnoid membrane of the brain or spinal cord) Baclofen therapy. Gablofen is specifically targeted at spasticity traced to spinal and cerebral causes, and is marketed under Covidien’s pharmaceuticals brand Mallinckrodt. Prefilled syringes of Gablofen will be marketed beginning in February. It will be sold in vials of various concentrations.

Covidien is headquartered in Dublin, Ireland. The firm’s U.S. base is in Mansfield, Mass. The company has been quite acquisitive in the past year, scooping up several companies with the aim of diversification and development of new products and technologies. In October last year, Covidien’s pharmaceuticals business Mallinckrodt acquired CNS Therapeutics Inc., a St. Paul Minn.-based specialty pharmaceutical company, for approximately $100 million. Covidien plans to spin-off its pharmaceutical business by mid-2013 to focus on its high-margin surgical products portfolio.